MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-24 for LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC 2914A2-LT manufactured by 3m Espe Dental Products.
[68349742]
On the basis of the information provided, it is not known what role, if any, lava ultimate played in the reported outcome. Other factors, such as prior tooth history and dental treatments (including the use of a non-recommended cement type), may have played a role in the need for the reported root canal treatment.
Patient Sequence No: 1, Text Type: N, H10
[68349743]
On january 27, 2017, a dentist reported the case of a female patient in her (b)(6) (yob 1973) who required root canal treatment on tooth #13. This tooth had a lava ultimate crown seated on (b)(6) 2014, to replace an existing large amalgam. On august 13, 2014, the patient reported sensitivity to pressure and a bite adjustment was performed. The crown debonded on (b)(6) 2016, and was re-cemented with a non-recommended glass ionomer cement. On april 18, 2016, the patient reported cold sensitivity. The crown was removed on (b)(6) 2016, and a ring of soft tooth structure around the margin was noted. At this time, the tooth was re-prepped, build-up completed, and a non-3m crown was placed. During a routine hygiene visit, on september 15, 2016, the patient reported sensitivity and a bite adjustment for he non-3m crown was performed. On (b)(6) 2016, the patient received root canal treatment performed by another dentist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00021 |
| MDR Report Key | 6358626 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-24 |
| Date of Report | 2017-01-27 |
| Date of Event | 2016-11-17 |
| Date Mfgr Received | 2017-01-27 |
| Date Added to Maude | 2017-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS-IRVINE |
| Manufacturer Street | 2111 MCGAW AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2052-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC |
| Generic Name | MATERIAL, TOOTH SHADE RESIN |
| Product Code | EBF |
| Date Received | 2017-02-24 |
| Catalog Number | 2914A2-LT |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-24 |